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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement
510(k) Number K213812
Device Name PALACOS MV pro
Applicant
Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
Wehrheim,  DE 61273
Applicant Contact Ljuba Jaeckel
Correspondent
Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
Wehrheim,  DE 61273
Correspondent Contact Ljuba Jaeckel
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Codes
JDZ   KIH  
Date Received12/07/2021
Decision Date 02/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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